MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-09-28 for IMMULITE 2000 ERYTHROPOIETIN IMMULITE 2000 XPI manufactured by Siemens Healthcare Diagnostics.
[2890299]
Discordant erythropoietin (epo) results were obtained on 2 samples from the same patient on the immulite 2000 xpi instrument, where diluted results did not match the neat values. The initial result (neat) was reported to the physician, who questioned the result and requested a dilution. The customer performed one manual dilution followed by serial dilutions, and then obtained a second sample tube from the patient and repeated the same process using a different reagent lot. The customer did not report out any of the rerun results, and stated that they would discuss the results with the physician to determine if the sample should be sent to an alternate laboratory. There were no reports of patient intervention or adverse health consequences due to the discordant epo result.
Patient Sequence No: 1, Text Type: D, B5
[10138499]
A siemens field service engineer was not dispatched to the customer site because the customer declined service. Based upon the results, the customer stated that they believed the issue was sample specific. The cause of the discordant epo results is unknown. Siemens has requested the sample for further testing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00322 |
| MDR Report Key | 2764760 |
| Report Source | 05,06 |
| Date Received | 2012-09-28 |
| Date of Report | 2012-08-31 |
| Date of Event | 2012-08-31 |
| Date Mfgr Received | 2012-08-31 |
| Date Added to Maude | 2013-01-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MINDY LOSAPIO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242312 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | 62 FLANDERS BARTLEY RD |
| Manufacturer City | FLANDERS NJ 07836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07836 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 ERYTHROPOIETIN |
| Generic Name | IMMULITE 2000 XPI |
| Product Code | GGT |
| Date Received | 2012-09-28 |
| Model Number | IMMULITE 2000 XPI |
| Lot Number | 318 & 319 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 62 FLANDERS BARTLEY RD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-28 |